MAUDE Adverse Event Report: EXACTECH, INC. EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products - eq rev adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6).36mm humeral liner unconstrained +0 (cat# 320-36-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, over time, the 71 y/o female patient was loose and unstable, so the surgeon upsized all options while leaving the well-fixed stem.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to hospital policy.

• Brand Name: EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18678431
• MDR Text Key: 335030618
• Report Number: 1038671-2024-00187
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE
• Device Catalogue Number: 320-32-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female